A robust pharmacovigilance system is essential for the success of public health programmes. When new medicines or vaccines are used in large populations in a short timeframe, it is essential that safety information is gathered quickly to ensure the success of the product launch. New medicines and vaccines are much needed to treat and prevent disease, and this is particularly important in low- and middle-income countries (LMICs). Increasingly, such new medicines or vaccines are used for the first time in such settings, the uncertainties around their safety are greater, and the need for effective pharmacovigilance all the more compelling.